WASHINGTON -- The FDA has approved over-the-counter sale of the emergency contraceptive Plan B One-Step (levonorgestrel) to women and girls as young as 15.
that the approval was based on actual use studies and label-comprehension data showing that girls and women 15 and older understood that the product was not for routine use and wouldn't prevent sexually transmitted diseases.
On April 5, a federal judge in the U.S. District Court's Eastern District of New York reversed a decision from the Department of Health and Human Services that restricted OTC access to levonorgestrel-containing emergency contraceptives Plan B and Plan B One-Step to women and girls 17 and older.
"Secretary Sebelius's directive to the FDA ... forced the agency to ride roughshod over the policies and practices that it has consistently applied in considering applications for switches in drug status to over-the-counter availability," Judge Edward Korman wrote in his opinion.
Korman gave the agency 30 days to approve an OTC version without age restrictions, but the FDA acted, instead, on the application before it. Manufacturer Teva Women's Health asked only for OTC extension to age 15. The agency said in a statement that "this decision is not intended to address the judge's ruling."
There will be several protections to limit the sale to those younger than 15, the FDA said.
For example, the product will be labeled "not for sale to those under 15 years of age *proof of age required* not for sale where age cannot be verified." Cashiers will be prompted by product code to verify the customer's age.
Also, the manufacturer, Teva Women's Health, will have a security tag on the carton to prevent theft.
"Research has shown that access to emergency contraceptive products has the potential to further decrease the rate of unintended pregnancies in the United States," FDA Commissioner Margaret A. Hamburg, MD, said in a statement. "The data reviewed by the agency demonstrated that women 15 years of age and older were able to understand how Plan B One-Step works, how to use it properly, and that it does not prevent the transmission of a sexually transmitted disease."
The Planned Parenthood Federation of America supported Tuesday's decision.
"While there are still practical questions to resolve, this is an important step forward to expand access to emergency contraception and for preventing unintended pregnancy," President Cecile Richards said in a statement. "Emergency contraception is a safe and effective form of birth control that can prevent pregnancy if taken within 5 days of unprotected sex. This decision will eliminate some of the biggest barriers and hurdles that women face in getting emergency contraception when they need it, which means many more women will be able to prevent unintended pregnancy."
Plan B was first approved for use in 1999 by prescription only; the FDA granted over-the-counter access to the pill for women 18 and older while maintaining the prescription requirement for younger females in 2006.